An interventional study of Blood Draw in Venous Ulcers, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Screening
Currently, there is no standard approach for the treatment of patients with venous stasis ulcers, and no means of accounting for the genetic factors that may contribute to a patient's response to different therapeutic interventions. In order to determine whether, or to what extent, genetic profiling of venous stasis ulcers can stratify patients according to their potential for disease progression or healing, and guide preventive strategies and levels of therapeutic interventions, the study will involve retrospective genetic profiling of patients with a healed or persistent venous stasis ulcer as a means of determining the efficacy of current therapies, and to establish a future prospective evaluation of treatment algorithms based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups of participants will be compared with those of a control group of participants who have no history of venous ulcer nor peripheral vascular disease.
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A blood specimen will be drawn, medical and medication history taken, and wound/s will be assessed and followed for 2 years in regard to the enrollees w/active venous ulcer/s or healed venous ulcer/s.
A venous duplex ultrasound of right and left lower extremities will be done at no cost, a blood specimen will be drawn, and medical and medication history will be taken in regard to control group enrollees.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 377 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Group 1-Active venous ulcer (CEAP 6) \& Group 2-Healed venous ulcer (CEAP 5)
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
One blood draw at enrollment
Procedure: Blood Draw
One blood draw at enrollment
Ulcer healing
Time to ulcer healing
Time frame: Assessment made when batch of samples (360) obtained
Ulcer recurrence
Presence of ulcer recurrence
Time frame: Assessment made when batch of samples (360) obtained
Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence
Time frame: Assessment made when batch of samples (360) obtained
Analysis of association between clinical variables and genetic testing results
Time frame: Assessment made when batch of samples (360) obtained
Analysis of clinical variables in conjunction with ulcer healing and recurrence
Time frame: Assessment made when batch of samples (360) obtained
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh